Effect of Thread Embedding Acupuncture on Postoperative Ileus Recovery After Colorectal Cancer Surgery: A Multicenter Randomized Controlled Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-01

Study Completion Date

2027-07-31

Brief Summary

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This multicenter, randomized, controlled trial aims to evaluate the efficacy and safety of thread embedding acupuncture (TEA) in promoting gastrointestinal recovery after laparoscopic colorectal cancer surgery. The primary outcome is the time to first flatus. Secondary outcomes include time to first defecation, tolerance to oral intake, length of hospital stay, and patient-reported quality of life.

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Detailed Description

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Conditions

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Colorectal Cancer Postoperative Ileus LARS - Low Anterior Resection Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Participants were blinded to their group assignment. In the sham group, blunt needles were placed at the same acupoints using adhesive pads without skin penetration or electrical stimulation, simulating the appearance of real thread embedding. Outcome assessors and investigators responsible for data collection and analysis were also blinded to the group allocation. Care providers performing the procedure were not blinded due to the nature of the intervention.

Study Groups

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Thread embedding+Electroacupuncture Group

Thread embedding at bilateral ST36, ST37, and PC6 at 2h after surgery and Electroacupuncture at same location at 2h, 24h, 48h, and 72h postoperatively

Group Type EXPERIMENTAL

Thread Embedding Acupuncture+Electroacupuncture

Intervention Type PROCEDURE

Thread embedding acupuncture will be administered at bilateral ST36, ST37, and PC6 acupoints at 2h after surgery and electroacupuncture at same acupoints at 2h 24h, 48h, and 72h after surgery. Absorbable polydioxanone sutures will be embedded into subcutaneous tissue using sterile embedding needles. All procedures will be conducted by licensed acupuncturists following standardized operating protocols.

Electroacupuncture Group

Electroacupuncture

Group Type OTHER

Electroacupuncture

Intervention Type PROCEDURE

Electroacupuncture will be performed at the same bilateral acupoints (ST36, ST37, and PC6)

Control Group

Standard perioperative management without any acupuncture-related intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Thread Embedding Acupuncture+Electroacupuncture

Thread embedding acupuncture will be administered at bilateral ST36, ST37, and PC6 acupoints at 2h after surgery and electroacupuncture at same acupoints at 2h 24h, 48h, and 72h after surgery. Absorbable polydioxanone sutures will be embedded into subcutaneous tissue using sterile embedding needles. All procedures will be conducted by licensed acupuncturists following standardized operating protocols.

Intervention Type PROCEDURE

Electroacupuncture

Electroacupuncture will be performed at the same bilateral acupoints (ST36, ST37, and PC6)

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

Age 18-80 years Diagnosed with stage I-III colorectal cancer Scheduled for elective laparoscopic colorectal resection ASA Physical Status I-III Ability to provide informed consent

Exclusion Criteria

History of prior major abdominal surgery Emergency or palliative surgery Combined organ resection or open conversion Severe postoperative complications (e.g., anastomotic leak, GI bleeding) Severe cardiac, hepatic, renal, or psychiatric comorbidities Refusal to undergo acupuncture

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No